Flexible applicator for inserting an article into a mammalian body cavity

ABSTRACT

The present invention relates to a flexible applicator for inserting an article into a mammalian body cavity. The applicator has an elongate, hollow, structural member suitable for containing the insertable article, and an elongate expulsion member which is slidable within the structural member. The structural member has opposed inside and outside surfaces, and its length dimension is substantially greater than its width and height dimension. In addition, the structural member has a plurality of flex-enhancing elements which are arranged and configured to increase the lateral flexibility of the structural member.

This is a Divisional of prior application No.: 08/885,719, filed Jun.30, 1997, now U.S. Pat. No. 6,019,743.

FIELD OF THE INVENTION

The present invention relates to flexible devices for inserting anarticle into a mammalian body cavity. In particular, the insertiondevice has an elongate, hollow structural member which has a pluralityof flex-enhancing elements which increase its lateral flexibility.

BACKGROUND OF THE INVENTION

Hollow insertion devices, such as tampon applicators, are generallyconstructed of one of two basic materials: plastic and cardboard. Whilecardboard applicators are generally more rigid than plastic applicators,neither material easily conforms to the body cavity in which theapplicator is inserted. Attempts to enable an applicator to more closelyconform to a body cavity, such as a vagina, have included tamponapplicators, such as those described in Paul et al., U.S. Pat. Nos.5,158,535 and 5,267,953; and Fox et al., U.S. Pat. No. 5,437,628.Unfortunately, this approach suffers in two major areas: first, not allusers have the same body shape, and second, the use of these curveddevices requires the user to carefully orient the applicator during use.This must often be done in cramped bathrooms with poor visual control.

In view of the poor ability of the prior art to conform to manydifferent body shapes, what is needed is an applicator device which issufficiently rigid to permit insertion of an article into a body cavityand which also retains sufficient flexibility to conform to individualusers' unique body shape.

SUMMARY OF THE INVENTION

The present invention relates to a flexible applicator for inserting anarticle into a mammalian body cavity. The applicator has an elongate,hollow, structural member suitable for containing the insertablearticle, and an elongate expulsion member which is slidable within thestructural member. The structural member has opposed inside and outsidesurfaces, and its length dimension is substantially greater than itswidth and height dimension. In addition, the structural member has aplurality of flex-enhancing elements which are arranged and configuredto increase the lateral flexibility of the structural member.

The flexible applicator of the present invention may be used as tamponapplicators for feminine hygiene, or for the vaginal or rectal deliveryof prophylactic compositions and/or medicaments.

The invention also relates to a method of forming a flexible applicator.In this method, flex-enhancing elements are formed in a structuralmember having an outer surface, a layer of a flexible material issuperposed on the outer surface of the structural member, and thestructural member is formed into an elongate, hollow member suitable forcontaining the insertable article. The hollow member has opposedinsertion and gripper ends.

The flexible material may be laminated to the outer surface of thestructural member by (i) applying a laminating material to the outersurface of the structural member and (ii) applying the flexible materialto the laminating material.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1 is a plan view of a double blank useful in forming a tamponapplicator according to the present invention which employs relativelynarrow slots as the flex-enhancing elements.

FIG. 2 is a partially cut-away plan view of a blank useful in forming atampon applicator according to the present invention.

FIG. 3 is a side elevation of a tampon applicator according to thepresent invention.

FIG. 4 is a cross-section taken along line 4—4 of FIG. 3.

FIG. 5 is a perspective view of a tampon applicator according to thepresent invention which has been curved.

FIG. 6 is a partially cut-away, exploded view of a portion of the tamponapplicator of FIG. 5.

FIGS. 7-9 are plan views of alternative embodiment blanks useful informing a tampon applicator according to the present invention whichemploy wide slots, slits, and cut-outs, respectively, as theflex-enhancing elements.

FIG. 10 is a partially cut-away side elevation view of an alternativeembodiment of a tampon applicator according to the present inventionwhich employs folds as the flex-enhancing elements.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

A preferred embodiment of the present invention is illustrated in FIG.3, i.e., a tampon applicator 10 for vaginal insertion of a catamenialtampon 12. The tampon applicator 10 comprises an outer barrel 14 and aplunger 16 which is slidable within the barrel 14 to eject the tampon 12therefrom. The barrel 14 is an elongate, hollow, structural member. Ithas opposed inside and outside surfaces, a length dimension which issubstantially greater than its width and height dimensions, and opposedinsertion 18 and gripper 20 ends. The barrel 14 also has a plurality offlex-enhancing elements (illustrated as slots 22) formed therein whichare arranged and configured to increase its lateral flexibility. Theplunger 16 may also incorporate flex-enhancing elements (not shown) intoits structure to increase its lateral flexibility in a manner similar tothe barrel 14.

The barrel 14 may also have a plurality of petals 24 formed at theinsertion end 18 to allow the end to be substantially closed. Theclosure of the insertion end 18 can take on any configuration, includingwithout limitation, domed, conical, elliptical, etc.

The gripper end 20 may have features to help the user grip the barrelmore securely during use. These features are shown as large apertures26, but they may also include raised structures, indentations orgrooves, friction-increasing coatings, etc.

In a preferred embodiment, the barrel 14 also has a flexible material 28disposed on its outside surface. This flexible material 28 may beattached to the barrel by an intermediate layer, such as an adhesive 30,to form a laminate, or it may be coated directly onto the outsidesurface of the barrel 14. Other methods of attaching the flexiblematerial 28 to the barrel 14 will be readily recognized by one ofordinary skill in the art. In certain embodiments of the invention suchas those of FIGS. 1-7 and 9, it may be appropriate to apply thelaminating adhesive 30 onto the outside surface of the barrel 14 orbarrel-forming material prior to applying the flexible material 28thereto. In other embodiments, more conventional methods of coatingand/or laminating may be used.

Optionally, a second flexible material 29 may be disposed on the insidesurface of the barrel 14 by means of a second intermediate layer such asadhesive 31. This second flexible material 29 may help to reduce oreliminate the opportunities of the tampon 12 to be caught on the edges21, 23 of perforated flex-enhancing elements.

Flex-enhancing elements useful in the operation of the present inventioninclude, without limitation, perforations, such as slits, slots,cut-outs, and the like (including perforations which extend through lessthan the complete thickness of the structural member or one or morelayers in a laminate forming this member); folds, scores, and the like.Preferably, the flex-enhancing elements are disposed along the length ofthe barrel 14. They may either be aligned along this length, or they maybe arranged in a substantially offset, alternating pattern. When theflex-enhancing elements are aligned along the length, the applicator 10will generally have flexibility primarily in one plane through itscentral axis. When they are offset (as shown in FIGS. 8 and 9), theapplicator will generally have flexibility in more than one plane.

When the structural member forming the barrel 14 has the preferredflexible material 28 disposed on its outside surface, the flex-enhancingelements may result in the segmentation of the structural member intodiscrete units such as short lengths of tube which are substantiallyshorter than their diameter. These segments will then be held togetherand maintained as a flexible barrel 14 by the outer flexible material 28and optionally by the inner flexible material 29. The flex-enhancingelements may also be the result of a continuous spiral slit whichresults in a plurality of slits when viewed in longitudinalcross-section. Again, this type of flex-enhancing elements would benefitfrom the use of at least the outer flexible material 28 to hold thestructural material together as a barrel 14. The flex-enhancing elementsare preferably arranged and configured to substantially maintain thelongitudinal compressive strength of the structural member. Thus, theuser is able to maintain control of the insertion device, especially thebarrel 14, during its insertion into the body cavity.

In a particularly preferred embodiment, the flex enhancing elements inthe barrel 14 are perforations which have edges 21, 23. Theseperforations may have a major axis and a minor axis. Preferably, themajor axis of the flex-enhancing elements is oriented substantiallyperpendicular to the length of the applicator. The edges 21, 23 of theperforations may abut (for example, the slits 22A shown in FIG. 8) orthey may be separated (for example, the slots 22 shown in FIG. 3 and thecut-outs 22B shown in FIG. 9) when the barrel 14 is in a relaxed,unstressed state. When the barrel 14 is subjected to forces having acomponent perpendicular to the longitudinal axis, the flex-enhancingelements allow the barrel 14 to flex into a curved orientation as shownin FIG. 5. In the curved orientation, the edges 21A, 23A of slits 22Awill separate, while the edges 21, 23 of slots 22 will generally closeas shown in FIG. 6. While this discussion focuses on flex-enhancingelements in the barrel 14, it is also applicable to flex enhancingelements (not shown) in the plunger 16.

In the alternative embodiment illustrated in FIG. 10, the flex-enhancingelements in the barrel 14 comprise a fold 22C. In this embodiment, thefold 22C is directed substantially inward from the outside surface ofthe barrel 14. This inward direction of the fold 22C allows the outsidesurface to remain substantially smooth. In this embodiment, it is likelythat the tampon 12 will have a smaller diameter, or the barrel 14 willhave a larger diameter to allow for the annular space occupied by thefolds 22C.

The barrel 14 may be made of structural materials generally known tothose of ordinary skill in the art. These materials include, withoutlimitation, plastic sheet; moldable plastic, such as injection-moldableor blow-moldable plastic; biodegradable plastic, such as those disclosedin the commonly assigned application, Dabi et al., U.S. Ser. No.08/006,013, filed Jan. 15, 1993 (herein incorporated by reference); andcardboard. The cardboard used as structural materials can be a singlelayer of cardboard material, or it can be a plurality of laminatedlayers to provide multiple benefits relating to the various layers.Useful cardboard stock for the formation of the tubular elementsinclude, without limitation, paperboard, cardboard, cup stock, paper,and the like.

The structural material preferably has disposed thereon the flexiblematerial 28 generally discussed above to provide aesthetics similar toconventional plastic-coated or plastic-laminated cardboard applicators.This flexible material 28 is preferably a substantially continuous layerwhich spans and is unsupported by the structural material at theflex-enhancing elements. The flexible material 28 may be a plastic film,an elastomeric film, coated paper, and the like. Useful plasticsinclude, without limitation, polyolefins such as polyethylene andpolypropylene, polyesters such as polyethylene terephthalate,polycaprolactone, polyvinyl alcohol, ethylene-vinyl acetate copolymers,cellophane, and the like. Useful elastomers include, without limitation,natural rubber, styrene-butadiene copolymers, isobutylene-isoprenecopolymers, polychloroprene systems (Neoprene Registered TM, duPont),polyurethanes, polysulfide rubbers, polyacrylate elastomers comprisingthe copolymerization of ethyl acrylate and acrylic acid-lower alkanolesters, nitrile rubber, butyl rubber, polysulfide rubber, polyisoprene,ethylene-propylene terpolymers such as EDPM rubber, silicone rubber, andthe like. Useful coated papers include waxed paper, plastic-coatedpaper, silicone-coated paper, and the like.

Preferred structural materials include cardboards and laminatedcardboards. These plastic laminated cardboard materials may includeadditional layers such as adhesive layers, tie layers, and the like.

Typical dimensions for the barrel 14 useful in tampon applicatorsinclude a length of about 5 to 8 cm, a diameter of about 8 to 16 mm, andthicknesses of about 0.4 to 0.6 mm. Preferably, the diameter of theplunger 16 is less than the diameter of the barrel 14 to allow for atelescopic arrangement of the plunger 16 within the barrel 14 as shownin FIG. 3.

The insertion device can be formed in several ways currently known tothose of ordinary skill in the art. Tubular structural members may beformed as a continuous spiral-wound tube and subsequently cut to formthe tubular elements. On the other hand, individual tubular elements orshorter tubes can be formed from rectangular sheets (or blanks) ofcardboard. These blanks can be rolled about a central axis X in themanner indicated in FIG. 2 and secured with longitudinal seams 32 asshown in FIG. 4. This is shown in greater detail in Hinzmann, U.S. Pat.No. 4,755,164, herein incorporated by reference. Alternatively, they canbe convolutely wound as disclosed in Whitehead, U.S. Pat. No. 4,508,531.The shorter tubes can be cut to form a small number of tubular elements,similar to the continuous, spiral-wound tubes.

In use, the user simply removes the tampon applicator 10 from anyprotective wrappers in which it may be packaged, holds the gripper end20 and inserts the insertion end 18 of the applicator into the vagina.After insertion of the applicator 10, the expulsion member 16 is pushedinto the barrel 14 to expel the tampon 12 from the barrel 14, and intothe vagina. The applicator 10 is then withdrawn from the vagina and maybe discarded.

While the detailed description above relates to a preferred embodimentof insertion devices, i.e., a tampon applicator, one of ordinary skillin the art will readily recognize that the same device can be used forthe vaginal or rectal delivery of prophylactic compositions, such asspermicides, and/or medicaments, such as fungicides. These compositionsand/or medicaments may be in the form of solids, creams, foams, gels,and the like.

The specification and embodiments above are presented to aid in thecomplete and non-limiting understanding of the invention disclosedherein. Since many variations and embodiments of the invention can bemade without departing from its spirit and scope, the invention residesin the claims hereinafter appended.

What is claimed is:
 1. A flexible applicator for inserting an articleinto a mammalian body cavity comprising: a) an elongate, hollow,structural member suitable for containing the insertable article, thestructural member having opposed inside and outside surfaces, a lengthdimension which is substantially greater than both a width and a heightdimension, an insertion end and an opposed gripper end comprising atleast one grip-enhancing feature, and a plurality of flex-enhancingelements which are arranged and configured intermediate the insertionand gripper ends to provide lateral flexibility to an insertable portionof the structural member and to substantially maintain sufficientlongitudinal compressive strength of the structural member to resistcollapse in the longitudinal direction; and b) an elongate expulsionmember which is slideable within the structural member.
 2. The flexibleapplicator of claim 1 wherein the flex-enhancing elements are disposedalong the length of the structural member.
 3. The flexible applicator ofclaim 1 wherein the flex-enhancing elements comprise perforations havingedges.
 4. The flexible applicator of claim 3 wherein the perforationsare closely spaced.
 5. The flexible applicator of claim 3 wherein theedges are spaced apart.
 6. The flexible applicator of claim 3 whereinthe flex-enhancing elements comprise a fold.
 7. The flexible applicatorof claim 6 wherein the fold is directed substantially inwardly wherebythe outside surface of the structural member is substantially smooth. 8.The flexible applicator of claim 1 wherein the insertion end issubstantially closed.
 9. The flexible applicator of claim 1 wherein theflex-enhancing elements have a major axis and a minor axis, and themajor axis is oriented substantially perpendicular to the length of theapplicator.
 10. The flexible applicator of claim 1 wherein theflex-enhancing elements are substantially aligned along the length ofthe structural member.
 11. The flexible applicator of claim 1 whereinthe elongate, hollow, structural member comprises a substantiallycylindrical tube.
 12. A flexible applicator for inserting an articleinto a mammalian body cavity comprising: a) an elongate, hollow,structural member suitable for containing the insertable article, thestructural member having opposed inside and outside surfaces, a lengthdimension which is substantially greater than both a width and a heightdimension, an insertion end and an opposed gripper end comprising atleast one grip-enhancing feature, and means intermediate the insertionand gripper ends to provide lateral flexibility to an insertable portionof the structural member and to substantially maintain sufficientlongitudinal compressive strength of the structural member to resistcollapse in the longitudinal direction; and b) an elongate expulsionmember which is slideable within the structural member.
 13. The flexibleapplicator of claim 12 wherein the means to provide lateral flexibilityis disposed along the length of the structural member.
 14. The flexibleapplicator of claim 12 wherein the insertion end is substantiallyclosed.